Smart Port CT CT80STPA-VIRecalls & reported problems
Angiodynamics, Inc. · Smart Port CT Single Titanium Port System with Attached 8.0F x 66cm Polyurethane Catheter and 8 F Introducer Kit (with Valved Introducer) · Class 2 · Implant
All models of Smart Port CT (36)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI H787CT80STPAVI1), received between Apr 20, 2017 and Apr 20, 2017 — classified as 2 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Fracture” (8 reports).
2 other recalls cover devices cleared under the same FDA submission (K062414); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Fracture8
- Leak/Splash8
Patient problems
- No Known Impact Or Consequence To Patient8
- Pain8
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjuryApr 20, 2017Fracture; Leak/Splash; Fracture; Leak/Splash
AS REPORTED TO ANGIODYNAMICS ON (B)(6) 2017: WHEN FLUSHING THE PORT, THE PATIENT REPORTED EXPERIENCING SLIGHT PAIN. IT WAS NOTED THE PORT CATHETER HAD FRACTURED. IT WAS REPORTED THE DEFECTIVE DEVICE WAS REMOVED. THE PATIENT DID NOT SUFFER ANY ADVERSE EFFECT DUE TO THIS EVENT. IT WAS REPORTED THAT THE DISPOSABLE DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.
Patient problems: No Known Impact Or Consequence To Patient; Pain
MAUDE report 6508050 ↗MalfunctionApr 20, 2017Fracture; Leak/Splash; Fracture; Leak/Splash
AS REPORTED TO ANGIODYNAMICS ON (B)(6) 2017: PATIENT WAS RECEIVING CHEMOTHERAPY VIA PORT. THE PORT WAS FLUSHED 6-8 WEEKS IF NOT IN USE. THIS PORT WAS CURRENTLY IN USED WEEKLY. WHEN FLUSHING THE PORT, THE PATIENT REPORTED EXPERIENCING SLIGHT PAIN. IT WAS NOTED THE PORT CATHETER HAD FRACTURED. IT WAS REPORTED THE DEFECTIVE DEVICE WAS REMOVED. THE PATIENT DID NOT SUFFER ANY ADVERSE EFFECT DUE TO THIS EVENT. IT WAS REPORTED THAT THE DISPOSABLE DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.
Patient problems: No Known Impact Or Consequence To Patient; Pain
MAUDE report 6508026 ↗InjuryApr 20, 2017Fracture; Leak/Splash; Fracture; Leak/Splash
AS REPORTED TO ANGIODYNAMICS ON MARCH 22, 2017: WHEN FLUSHING THE PORT, THE PATIENT REPORTED EXPERIENCING SLIGHT PAIN. IT WAS NOTED THE PORT CATHETER HAD FRACTURED. IT WAS REPORTED THE DEFECTIVE DEVICE WAS REMOVED. THE PATIENT DID NOT SUFFER ANY ADVERSE EFFECT DUE TO THIS EVENT. IT WAS REPORTED THAT THE DISPOSABLE DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.
Patient problems: No Known Impact Or Consequence To Patient; Pain
MAUDE report 6508022 ↗MalfunctionApr 20, 2017Fracture; Leak/Splash; Fracture; Leak/Splash
AS REPORTED TO ANGIODYNAMICS ON MARCH 22, 2017: PATIENT WAS RECEIVING CHEMOTHERAPY VIA PORT. THE PORT WAS FLUSHED 6-8 WEEKS IF NOT IN USE. THIS PORT WAS CURRENTLY IN USE EVERY 4 WEEKS. WHEN FLUSHING THE PORT, THE PATIENT REPORTED EXPERIENCING SLIGHT PAIN. IT WAS NOTED THE PORT CATHETER HAD FRACTURED. IT WAS REPORTED THE DEFECTIVE DEVICE WAS REMOVED. THE PATIENT DID NOT SUFFER ANY ADVERSE EFFECT DUE TO THIS EVENT. IT WAS REPORTED THAT THE DISPOSABLE DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.
Patient problems: No Known Impact Or Consequence To Patient; Pain
MAUDE report 6508021 ↗MalfunctionApr 20, 2017Fracture; Leak/Splash; Fracture; Leak/Splash
AS REPORTED TO ANGIODYNAMICS ON MARCH 22, 2017: PATIENT WAS RECEIVING CHEMOTHERAPY VIA PORT. THE PORT WAS FLUSHED 6-8 WEEKS IF NOT IN USE. THIS PORT WAS CURRENTLY IN USE EVERY 4 WEEKS. WHEN FLUSHING THE PORT, THE PATIENT REPORTED EXPERIENCING SLIGHT PAIN. IT WAS NOTED THE PORT CATHETER HAD FRACTURED. IT WAS REPORTED THE DEFECTIVE DEVICE WAS REMOVED. THE PATIENT DID NOT SUFFER ANY ADVERSE EFFECT DUE TO THIS EVENT. IT WAS REPORTED THAT THE DISPOSABLE DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.
Patient problems: No Known Impact Or Consequence To Patient; Pain
MAUDE report 6508011 ↗MalfunctionApr 20, 2017Fracture; Leak/Splash; Fracture; Leak/Splash
AS REPORTED TO ANGIODYNAMICS ON MARCH 22, 2017: PATIENT WAS RECEIVING CHEMOTHERAPY VIA PORT. THE PORT WAS FLUSHED 6-8 WEEKS IF NOT IN USE. THIS PORT WAS CURRENTLY IN USE EVERY WEEK. WHEN FLUSHING THE PORT, THE PATIENT REPORTED EXPERIENCING SLIGHT PAIN. IT WAS NOTED THE PORT CATHETER HAD FRACTURED. IT WAS REPORTED THE DEFECTIVE DEVICE WAS REMOVED. THE PATIENT DID NOT SUFFER ANY ADVERSE EFFECT DUE TO THIS EVENT. IT WAS REPORTED THAT THE DISPOSABLE DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.
Patient problems: No Known Impact Or Consequence To Patient; Pain
MAUDE report 6508008 ↗MalfunctionApr 20, 2017Fracture; Leak/Splash; Fracture; Leak/Splash
AS REPORTED TO ANGIODYNAMICS ON MARCH (B)(6) 2017: PATIENT WAS RECEIVING CHEMOTHERAPY VIA PORT. THE PORT WAS FLUSHED 6-8 WEEKS IF NOT IN USE. THIS PORT WAS CURRENTLY IN USE EVERY 2 WEEKS. WHEN FLUSHING THE PORT, THE PATIENT REPORTED EXPERIENCING SLIGHT PAIN. IT WAS NOTED THE PORT CATHETER HAD FRACTURED. IT WAS REPORTED THE DEFECTIVE DEVICE WAS REMOVED AND REPLACED. THE PATIENT DID NOT SUFFER ANY ADVERSE EFFECT DUE TO THIS EVENT. IT WAS REPORTED THAT THE DISPOSABLE DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.
Patient problems: No Known Impact Or Consequence To Patient; Pain
MAUDE report 6507993 ↗MalfunctionApr 20, 2017Fracture; Leak/Splash; Fracture; Leak/Splash
AS REPORTED TO ANGIODYNAMICS ON MARCH 22, 2017: PATIENT WAS RECEIVING CHEMOTHERAPY VIA PORT. THE PORT WAS FLUSHED 6-8 WEEKS IF NOT IN USE. THIS PORT WAS CURRENTLY IN USE EVERY 2 WEEKS. WHEN FLUSHING THE PORT, THE PATIENT REPORTED EXPERIENCING SLIGHT PAIN. IT WAS NOTED THE PORT CATHETER HAD FRACTURED. IT WAS REPORTED THE DEFECTIVE DEVICE WAS REMOVED AND REPLACED. THE PATIENT DID NOT SUFFER ANY ADVERSE EFFECT DUE TO THIS EVENT. IT WAS REPORTED THAT THE DISPOSABLE DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.
Patient problems: No Known Impact Or Consequence To Patient; Pain
MAUDE report 6507981 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K062414. One submission often covers many models, so check the product and lot details in each record.
- Z-1466-2021 · Feb 22, 2021 · TerminatedSmart Port CT-Implantable Port Catalogue #: CT96STSD-VI, CT96STSA-VI - Product Usage: indicated for any patient requiring repeated access of the vascular system, for delivery of me
- Z-0056-2012 · Aug 1, 2011 · Terminated8F Smart Port CT, Catalog number: CT80STPD and CT80STPD-NF; AngioDynamics, INC. The Smart Port CT Implantable Port is a Single Titanium Port System with Attachable 8.0 Fr. Polyur
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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